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A Clinical Efficacy Study Of Mongolian Medicine Shunqi Buxin Eleven Pills In The Treatment Of Hei-type Insomnia And Its Effect On Serum Cortisol Levels

A Clinical Efficacy Study Of Mongolian Medicine Shunqi Buxin Eleven Pills In The Treatment Of Hei-type Insomnia And Its Effect On Serum Cortisol Levels

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500113866
Enrollment
Unknown
Registered
2025-12-04
Start date
2025-12-04
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Insomnia

Interventions

Trial group:Take 15 tablets of Shunqi Buxin Shiyiwei Pills orally before bedtime,take continuously for 30 days.
Control group:Take 3 mg of zopiclone tablets orally before bedtime,take continuously for 30 days.

Sponsors

Inner Mongolia International Mongolian Medicine Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Meets diagnostic criteria for primary insomnia in Western medicine and Heyi Piansheng-type insomnia in Mongolian medicine; 2. Age 18 1 month; 4. PSQI score > 7 points; 5.Patients must be conscious and able to complete assessment questionnaires; 6.Patients who voluntarily enroll in the clinical study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Secondary insomnia caused by physical illness or mental disorders; 2. Individuals working night shifts or with irregular sleep schedules; 3.Hamilton Depression Rating Scale (HAMD-17) >=17, Hamilton Anxiety Rating Scale (HAMA) >=14; 4.Pregnant or lactating women; 5.Individuals with abnormal liver or kidney function; 6.Those currently receiving other insomnia-related treatments or using sleep-inducing medications;

Design outcomes

Secondary

MeasureTime frame
Insomnia Severity Index,ISI;Actigraphy monitoring: total sleep time, sleep efficiency, number of awakenings during the night, sleep latency, and wake time after sleep onset;Serum cortisol at 8:00 AM;

Primary

MeasureTime frame
Pittsburgh Sleep Quality Index, PSQI;Mongolian Medicine Syndrome Rating Scale;

Countries

China

Contacts

Public ContactDai Xuemei

Inner Mongolia International Mongolian Medicine Hospital

1161849016@qq.com+86 153 3281 5898

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026